To determine the effect of food on the repeated dose pharmacokinetics of SEN0014196 at 100 mg once daily in subjects with Huntington's disease [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

The effect of food on the PK of SEN0014196 will be evaluated for the following parameters: maximum observed plasma concentration (Cmax), time of maximum observed plasma concentration(tmax), AUC from time zero to the length of the dosing interval (tau) (AUC0-τ), AUC from time zero to the last quantifiable concentration (AUC0-last), AUC from time zero to infinity (AUC0-∞), terminal elimination half-life (t1/2), and terminal elimination rate constant (λz).

Subjects in the Fasted group will take study drug after an overnight fast (since at least midnight). Additionally, on PK assessment days, no food will be allowed for at least 4 hours after study drug administration.

Drug: SEN0014196

100 mg, immediate release tablets, once daily administration

Experimental: Fed condition

Subjects in the Fed group will take study drug within 30 minutes after starting breakfast; these subjects will otherwise maintain their normal eating schedule.

Drug: SEN0014196

100 mg, immediate release tablets, once daily administration

Detailed Description:

In addition to the pharmacokinetic endpoints, the study will assess the safety and tolerability of 100 mg once daily (qd) doses of SEN0014196 over 14 days in subjects with HD and explore potential biomarkers for use in subsequent Phase 2/3 studies.

Female subjects must be surgically sterile, postmenopausal, or willing to practice a highly effective method of contraception. All female participants must be nonlactating and nonpregnant. Male subjects must agree to use a reliable method of birth control during the study and for 3 months after the last dose of study drug.

Capable of providing informed consent

MMSE ≥24

Subjects must have a live-in competent observer

Exclusion Criteria:

Participation in a study or received an investigational drug within 30 days of the Baseline Visit

Any prior or concomitant use of compounds suspected of interfering with protein acetylation

Any concomitant use of medications that are known inhibitors of CYP450 enzymes or substrates of CYP1A2 at the time of enrollment

Suicide risk, as determined by meeting either of the following criteria: a) a suicide attempt within the past year or suicidal ideation within 60 days of the Screening Visit; b) Significant risk of suicide, as judged by the Investigator

Subjects with MMSE < 24

Subjects with presence of clinically significant psychosis and/or confusional states, in the opinion of the Investigator

Subjects with clinically significant laboratory or ECG abnormalities at Screening or Baseline

A history of malignancy of any type within 2 years prior to Screening. A history of surgically-excised nonmelanoma skin cancers is permitted.

Any relevant condition, behavior, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the subject unsuitable for entry into the study

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01485965